esolution® Esophageal Retractor
FDA 510(k) clearance K243233 · decided 2024-11-09
Clearance details
- K-number
- K243233
- Device name
- esolution® Esophageal Retractor
- Applicant
- S4 Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-09
- Decision date
- 2024-11-09
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- QXU
- Device class
- 2
- Regulation number
- 870.5710
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chagrin Falls, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| esolution (DEN230006) | S4 Medical Corp. | 2023-09-06 |
Recalls involving this device
No recalls on record reference this clearance.